QA Manager

Galway
Permanent
Are you looking for the next stage in your Quality career? GxP Recruitment have an exciting opportunity with our medical device client who are looking for a QA Manager to join their team in Galway.
Role/ Responsibilities:
  • Maintain company's Quality Management System (QMS) and report on the performance of the QMS to the company's Senior Management Team
  • Supervision of Quality Technicians and Quality Engineers. Lead quality personnel in the completion of required departmental activities including objectives/ goals.
  • Quality system oversight: management reviews, quality review and internal audit programme
  • Supplier control including: supplier audits, SCARs, performance monitoring and quality agreements
  • Manufacturing validation including: MVP development, PFMEAs, validation protocols and reports
  • Customer complaints: approval of analysis reports and analysis of complaint trends.
  • CAPA/NCR: oversight of the investigation and timely closure of CAPA and NCRs
  • Lot release: Routine sterilisation and lot release
  • External audits: lead the company in regulatory agency quality management system audits including FDA and Notified Body
  • Operations support: provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output.
  • Communicate with all functional groups to ensure awareness of quality requirements.
  • Update of the QMS to meet evolving regulatory and business requirements
Qualifications & Experience:
  • Bachelors in a scientific discipline required with 4 years’ experience in the medical device or pharmaceutical industry; strong analytical skills, exceptional writing and interpersonal relationship skills or a combination of relevant work experience and education.
  • Demonstrated knowledge of ISO 13485 and 21 CFR 820 requirements
  • Ability to work as part of a team and meet targets/goals efficiently.
  • Demonstrated organisational, management and communication skills.
  • Good interpersonal & communication skills essential
  • Strong knowledge of quality principles and the ability to utilize these methods in development and manufacturing environments.